YALE UNIVERSITY
HUMAN INVESTIGATION COMMITTEE
Application to Involve Human Subjects in Biomedical Research
100 FR1
Please refer to the HIC website for application HIC OFFICE USE ONLY
instructions and information required to
complete this application. The Instructions are DATE STAMPED-RECEIVED PROTOCOL NUMBER
available at http://www.yale.edu/hrpp/forms-
templates/index.html.
Submit the original application and two (2)
copies of all materials including relevant
sections of the grant which funds this project
(if applicable) to the HIC.
SECTION I: ADMINISTRATIVE INFORMATION
Title of Research Project:
Principal Investigator: Yale Academic Appointment:
Campus Address:
Campus Phone: Fax: Pager: E-mail:
Protocol Correspondent Name & Address (if different than PI):
Campus Phone: Fax: E-mail:
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable):
Campus Phone: Fax: E-mail:
Faculty Advisor:(required if PI is a student, Yale Academic Appointment:
resident, fellow or other trainee) NA
Campus Address:
Campus Phone: Fax: Pager: E-mail:
Does the principal investigator, co-investigator, or any other responsible research team member, or any of
their family members (spouse, child, domestic partner) have an incentive or interest, financial or otherwise,
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that may be viewed as affecting the protection of the human subjects involved in this project, the scientific
objectivity of the research or its integrity? See Disclosures and Management of Personal Interests in Human
Research http://www.yale.edu/hrpp/policies/index.html#COI
Yes No
If yes, list names of the investigator or responsible person:
SECTION II: GENERAL INFORMATION
1. Performing Organizations: Identify the hospital, in-patient or outpatient facility, school or
other agency that will serve as the location of the research. Choose all that apply:
a. Internal Location[s] of the Study:
Magnetic Resonance Research Center PET Center
(MR-TAC) YCCI/Church Street Research Unit (CSRU)
Yale Cancer Center/Clinical Trials Office (CTO) YCCI/Hospital Research Unit (HRU)
Yale Cancer Center YCCI/Keck Laboratories
Yale-New Haven Hospital Cancer Data Repository/Tumor Registry
Specify Other Yale Location:
b. External Location[s]:
APT Foundation, Inc. Haskins Laboratories
Connecticut Mental Health Center John B. Pierce Laboratory, Inc.
Clinical Neuroscience Research Unit (CNRU) Veterans Affairs Hospital, West Haven
Other Locations, Specify:
c. Additional Required Documents (check all that apply): N/A
*YCCI-Scientific and Safety Committee (YCCI-SSC) Approval Date:
*Pediatric Protocol Review Committee (PPRC) Approval Date:
*YCC Protocol Review Committee (YRC-PRC) Approval Date:
*Dept. of Veterans Affairs, West Haven VA HSS Approval Date:
*Radioactive Drug Research Committee (RDRC) Approval Date:
YNHH-Radiation Safety Committee (YNHH-RSC) Approval Date:
Magnetic Resonance Research Center PRC (MRRC-PRC) Approval Date:
YSM/YNHH Cancer Data Repository (CaDR) Approval Date:
Dept. of Lab Medicine request for services or specimens form
*Approval from these committees is required before final HIC approval is granted. See instructions
for documents required for initial submission and approval of the protocol. Allow sufficient time for
these requests. Check with the oversight body for their time requirements.
2. Probable Duration of Project: State the expected duration of the project, including all
follow-up and data analysis activities.
3. Targeted Enrollment: What is the:
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a. number of subjects targeted for enrollment at Yale for this protocol? If this is a multi-site study,
what is the total number of subjects targeted across all sites?
b. number of subjects expected to sign the consent form?
c. number of subjects expected to complete some or all interventions for this protocol?
4. Research Type/Phase: (Check all that apply)
a. Study Type
Single Center Study
Multi-Center Study
Does the Yale PI serve as the PI of the multi-site study? Yes No
Coordinating Center/Data Management
Other:
b. Study Phase N/A
Pilot Phase I Phase II Phase III Phase IV
Other (Specify)
c. Area of Research: (Check all that apply) Note that these are overlapping definitions and more
than one category may apply to your research protocol. Definitions for the following can be found
in the instructions section 4c:
Clinical Research: Patient-Oriented Clinical Research: Outcomes and
Clinical Research: Epidemiologic and Behavioral Health Services
Translational Research #1 (“Bench-to-Bedside”) Interdisciplinary Research
Translational Research #2 (“Bedside-to-Community”) Community-Based Research
5. Is this study required to be registered in a public database? Yes No
If yes, where is it registered?
Clinical Trials.gov registry
Other (Specify)
6. Will this research study utilize clinical care services at Yale New Haven Hospital or YMG?
Yes No
If yes, might these be billable to the subject, the sponsor, grant or other third party payer?
Yes No
If you answered "yes", please register this study in the IDX/GE system at
http://medicine.yale.edu/ymg/Images/10605-
FM.A_NewStudyRequest%20rev%20011310_tcm371-39390.pdf
7. Are there any procedures involved in this protocol that will be performed at YNHH or one of
its affiliated entities? Yes ___ No ___ If Yes, please answer questions a through c and note
instructions below. If No, proceed to Section III.
a. Does your YNHH privilege delineation currently include the specific procedure that you will
perform?
b. Will you be using any new equipment or equipment that you have not used in the past for
this procedure?
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c. Will a novel approach using existing equipment be applied?
If you answered “no” to question 7a, or "yes" to question 7b or c, please contact the YNHH
Department of Physician Services (688-2615) for prior approval before commencing with your
research protocol.
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING
1. Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply.
Provide information regarding the external funding source. This information should include
identification of the agency/sponsor, the funding mechanism (grant or contract), and whether
the award is pending or has been awarded. Provide the M/C# and Agency name (if grant-
funded). If the funding source associated with a protocol is “pending” at the time of the
protocol submission to the HIC (as is the case for most NIH submissions), the PI should note
“Pending” in the appropriate section of the protocol application, provide the M/C# and
Agency name (if grant-funded) and further note that University (departmental) funds support
the research (until such time that an award is made).
PI Title of Grant Name of Funding Source Funding Funding Mechanism
Federal Grant-M#
State Contract#
Non Profit Contract Pending
Industry Investigator/Department
Other For Initiated
Profit Sponsor Initiated
Other Other, Specify:
Federal Grant-M#
State Contract#
Non Profit Contract Pending
Industry Investigator/Department
Other For Initiated
Profit Sponsor Initiated
Other Other, Specify:
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Federal Grant-M#
State Contract#
Non Profit Contract Pending
Industry Investigator/Department
Other For Initiated
Profit Sponsor Initiated
Other Other, Specify:
IRB Review fees are charged for projects funded by Industry or Other For-Profit Sponsors.
Provide the Name and Address of the Sponsor Representative to whom the invoice should be
sent. Note: the PI’s home department will be billed if this information is not provided.
Send IRB Review Fee Invoice To:
Name:
Company:
Address:
2. Research Team: List all members of the research team. Indicate under the affiliation column whether
the investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff
from a collaborating institution, or are not formally affiliated with any institution. ALL members of
the research team MUST complete Human Subject Protection Training (HSPT) and Health
Insurance Portability and Accountability Act (HIPAA) Training before they may be listed on the
protocol. See NOTE below.
Name Affiliation
Principal Investigator
Role:
Role:
Role:
Role:
Role:
Role:
NOTE: The HIC will remove from the protocol any personnel who have not completed required training.
A personnel protocol amendment will need to be submitted when training is completed.
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SECTION IV:
PRINCIPAL INVESTIGATOR/FACULTY ADVISOR/ DEPARTMENT CHAIR
AGREEMENT
As the principal investigator of this research project, I certify that:
The information provided in this application is complete and accurate.
I assume full responsibility for the protection of human subjects and the proper conduct of the
research.
Subject safety will be of paramount concern, and every effort will be made to protect subjects’
rights and welfare.
The research will be performed according to ethical principles and in compliance with all federal,
state and local laws, as well as institutional regulations and policies regarding the protection of
human subjects.
All members of the research team will be kept apprised of research goals.
I will obtain approval for this research study and any subsequent revisions prior to my initiating the
study or any change and I will obtain continuing approval of this study prior to the expiration date
of any approval period.
I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to
participants.
I am in compliance with the requirements set by the University and qualify to serve as the
principal investigator of this project or have acquired the appropriate approval from the
Dean’s Office or Office of the Provost, or the Human Subject Protection Administrator at
Yale-New Haven Hospital, or have a faculty advisor.
I will identify a qualified successor should I cease my role as principal investigator and facilitate a
smooth transfer of investigator responsibilities.
_____
PI Name (PRINT) and Signature Date
As the faculty advisor of this research project, I certify that:
The information provided in this application is complete and accurate.
This project has scientific value and merit and that the student or trainee investigator has the
necessary resources to complete the project and achieve the aims.
I will train the student investigator in matters of appropriate research compliance, protection of
human subjects and proper conduct of research.
The research will be performed according to ethical principles and in compliance with all federal,
state and local laws, as well as institutional regulations and policies regarding the protection of
human subjects.
The student investigator will obtain approval for this research study and any subsequent revisions
Prior to initiating the study or revision and will obtain continuing approval prior to the expiration
of any approval period.
The student investigator will report to the HIC any serious injuries and/or other unanticipated
problems involving risk to participants.
I am in compliance with the requirements set forth by the University and qualify to serve as
the faculty advisor of this project.
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___________ ______ _____
Advisor Name (PRINT) and Signature Date
Department Chair’s Assurance Statement
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a
sponsoring company, patents, licensure) associated with this research project?
Yes (provide a description of that interest in a separate letter addressed to the HIC.)
No
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and
the sponsor of the research project, or its competitor or any interest in any intervention and/or method
tested in the project that might compromise this research project?
Yes (provide a description of that interest in a separate letter addressed to the HIC)
No
I assure the HIC that the principal investigator and all members of the research team are qualified by
education, training, licensure and/or experience to assume participation in the conduct of this research
trial. I also assure that the principal investigator has departmental support and sufficient resources to
conduct this trial appropriately.
____________________________
Chair Name (PRINT) and Signature Date
_________________________________
Department
YNHH Human Subjects Protection Administrator Assurance Statement
Required when the study is conducted solely at YNHH by YNHH health care providers.
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that:
I have read a copy of the protocol and approve it being conducted at YNHH.
I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest.
The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital
for this research project.
______________________________________
YNHH HSPA Name (PRINT) and Signature Date
For HIC Use Only
Date Approved Human Investigation Committee Signature
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SECTION V: RESEARCH PLAN
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.
2. Background: Describe the background information that led to the plan for this project. Provide
references to support the expectation of obtaining useful scientific data.
3. Research Plan: Summarize the study design and research procedures using non-technical language
that can be readily understood by someone outside the discipline. Be sure to distinguish between standard
of care vs. research procedures when applicable, and include any flowcharts of visits specifying their
individual times and lengths.
4. Statistical Considerations: Describe the statistical analyses that support the study design.
SECTION VI: RESEARCH INVOLVING DRUGS, BIOLOGICS, PLACEBOS AND DEVICES
If this section (or one of its parts, A or B) is not applicable, state N/A and delete the rest of the
section.
A. DRUGS and BIOLOGICS
1. Identification of Drug or Biologic: What is (are) the name(s) of the drug(s) or
biologic(s) being used? Identify whether FDA approval has been granted and for what indication(s).
All protocols which utilize a drug or biologic not approved by, but regulated by, the FDA must
provide the following information:
a. What is the Investigational New Drug (IND) number assigned by the FDA?
b. Who holds the IND?
Alternatively, an exemption from IND filing requirements may be sought for a clinical
investigation of a drug product that is lawfully marketed in the United States. If there is no IND and
an exemption is being sought, review the following categories and complete the category that applies
(and delete the inapplicable categories):
Exempt Category 1
The clinical investigation of a drug product that is lawfully marketed in the United States can be
exempt from IND regulations if all of the following are yes:
i. The intention of the investigation is NOT to report to the FDA as a well-controlled study in support
of a new indication for use or to be used to support any other significant change in the labeling for
the drug. Yes No
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ii. The drug that is undergoing investigation is lawfully marketed as a prescription drug product, and
the intention of the investigation is NOT to support a significant change in the advertising for the
product. Yes No
iii. The investigation does NOT involve a route of administration or dosage level or use in populations
or other factor that significantly increases the risks (or decreases the acceptability of the risks)
associated with the use of the drug product. Yes No
iv. The investigation will be conducted in compliance with the requirements for institutional (HIC)
review and with the requirements for informed consent of the FDA regulations (21 CFR Part 50
and 21 CFR Part 56). Yes No
v. The investigation will be conducted in compliance with the requirements regarding promotion and
charging for investigational drugs. Yes No
Exempt Category 2 (all items i, ii, and iii must be checked to grant a category 2 exemption)
i. The clinical investigation is for an in vitro diagnostic biological product that involves one or
more of the following (check all that apply):
Blood grouping serum
Reagent red blood cells
Anti-human globulin
ii. The diagnostic test is intended to be used in a diagnostic procedure that confirms the
diagnosis made by another, medically established, diagnostic product or procedure; and
iii. The diagnostic test is shipped in compliance with 21 CFR §312.160.
Exempt Category 3
The drug is intended solely for tests in vitro or in laboratory research animals if shipped in
accordance with 21 CFR 312.60
Exempt Category 4
A clinical investigation involving use of a placebo if the investigation does not otherwise
require submission of an IND.
2. Background Information: Provide a description of previous human use, known risks, and data
addressing dosage(s), interval(s), route(s) of administration, and any other factors that might
influence risks. If this is the first time this drug is being administered to humans, include relevant
data on animal models.
3. Source: a) Identify the source of the drug or biologic to be used.
b) Is the drug provided free of charge to subjects? Yes No
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If yes, by whom?
4. Preparation and Use: Describe the method of preparation, storage, stability information, and for
parenteral products, method of sterilization and method of testing sterility and pyrogenicity.
Note: If the YNHH IDS (or comparable service at CMHC or WHVA) will not be utilized, explain in
detail how the PI will oversee these aspects of drug accountability, storage, and preparation.
5. Use of Placebo: Not applicable to this research project
If use of a placebo is planned, provide a justification which addresses the following:
a. Describe the safety and efficacy of other available therapies. If there are no other
available therapies, state this.
b. State the maximum total length of time a participant may receive placebo while on the study.
c. Address the greatest potential harm that may come to a participant as a result of receiving
placebo.
d. Describe the procedures that are in place to safeguard participants receiving placebo.
6. Use of Controlled Substances:
Will this research project involve the use of controlled substances in human subjects?
Yes No See HIC Application Instructions to view controlled substance listings.
If yes, is the use of the controlled substance considered:
Therapeutic: The use of the controlled substance, within the context of the research, has the
potential to benefit the research participant.
Non-Therapeutic: Note, the use of a controlled substance in a non-therapeutic research study
involving human subjects may require that the investigator obtain a Laboratory Research License.
Examples include controlled substances used for basic imaging, observation or biochemical
studies or other non-therapeutic purposes. See Instructions for further information.
7. Continuation of Drug Therapy After Study Closure Not applicable to this project
Are subjects provided the opportunity to continue to receive the study drug(s) after the study has
ended?
Yes If yes, describe the conditions under which continued access to study drug(s) may apply
as well as conditions for termination of such access.
No If no, explain why this is acceptable.
B. DEVICES
1. Are there any investigational devices used or investigational procedures performed at YNHH, e.g.,
YNHH Operating Room or YNHH Heart and Vascular Center? Yes No
If Yes, please be aware of the following requirements:
a. A YNHH New Product/Trial Request Form must be completed;
b. Your request must be reviewed and approved by a Hospital Committee before
patients may be scheduled; and
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c. The notice of approval from YNHH must be submitted to the HIC for the protocol
file.
Please contact Gina D’Agostino, gina.d’agostino@ynhh.org or 688-5210, to initiate the process.
2. What is the name of the device to be studied in this protocol?
Has this device been FDA approved? Yes No
If yes, state for what indication.
3. Background Information: Provide a description of previous human use, known risks, and any
other factors that might influence risks. If this is the first time this device is being used in humans,
include relevant data on animal models.
4. Source:
a) Identify the source of the device to be used.
b) Is the device provided free of charge to subjects? Yes No
5. What is the PI’s assessment of risk level (significant or non-significant) associated with the use of
the device?
Significant Risk (SR) Device Study: A study of a device that presents a potential for serious
risk to the health, safety, or welfare of a participant and 1) is intended as an implant; 2) is used in
supporting or sustaining human life; or otherwise prevents impairment of human health; 3) is of
substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents
impairment of human health; or 4) otherwise presents a potential for serious risk to the health,
safety, or welfare of a participant.
Significant Risk Devices require an Investigational Device Exemption (IDE) issued by the FDA.
What is the IDE number assigned by the FDA?
Did the FDA approve this IDE as Category A (experimental/investigational) or as Category B
(non-experimental/investigational)?
Who holds the IDE?
Non-Significant Risk (NSR) Device Study: A study of a device that does not meet the
definition for a significant risk device and does not present a potential for serious risk to the health,
safety, or welfare of participants. Note that if the HIC concurs with this determination, an IDE is
not required.
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6. Abbreviated IDE or Exempt IDE: There are abbreviated requirements for an IDE and there also
are exemptions to the requirement for an IDE. See the criteria in the HIC Application Instructions,
Section VI.B.4 at http://www.yale.edu/hrpp/forms-templates/biomedical.html to determine if
these pertain to this study.
Abbreviated IDE or Exempt IDE – If criteria set forth in the HIC Application Instructions
are met, copy and paste the completed relevant section from the Instructions into this application.
7. Investigational device accountability:
a. State how the PI, or named designee, ensures that an investigational device is
used only in accordance with the research protocol approved by the HIC, and
maintains control of the investigational device as follows:
Maintains appropriate records, including receipt of shipment, inventory at the
site, dispensation or use by each participant, and final disposition and/or the return of the
investigational device (or other disposal if applicable):
Documents pertinent information assigned to the investigational device (e.g., date, quantity, batch
or serial number, expiration date if applicable, and unique code number):
Stores the investigational device according to the manufacturer's recommendations with respect to
temperature, humidity, lighting, and other environmental considerations:
Ensures that the device is stored in a secure area with limited access in accordance with applicable
regulatory requirements:
Distributes the investigational device to subjects enrolled in the IRB-approved protocol:
SECTION VII: HUMAN SUBJECTS
1. Subject Population: Provide a detailed description of the types of human subjects who will
be recruited into this study.
2. Subject classification: Check off all classifications of subjects that will be targeted for
enrollment in the research project. Will subjects who may require additional safeguards or other
considerations be enrolled in the study? If so, identify the population of subjects requiring special
safeguards and provide a justification for their involvement.
Children Healthy Fetal material, placenta, or dead fetus
Non-English Speaking Prisoners Economically disadvantaged persons
Decisionally Impaired Employees Pregnant women and/or fetuses
Yale Students Females of childbearing potential
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NOTE: Is this research proposal designed to enroll children who are wards of the state as
potential subjects? Yes No (If yes, see Instructions section VII #4 for further
requirements)
3. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or
exclusion?
4. How will eligibility be determined, and by whom?
5. Indicate recruitment methods below. Attach copies of any recruitment materials that will
be used.
Flyers Internet/Web Postings Radio
Posters Mass E-mail Solicitation Telephone
Letter Departmental/Center Website Television
Medical Record Review Departmental/Center Research Boards Newspaper
Departmental/Center Newsletters Web-Based Clinical Trial Registries
Other (describe): Clinicaltrials.gov Registry (do not send materials to HIC)
6. Recruitment Procedures:
a. Describe how potential subjects will be identified.
b. Describe how potential subjects are contacted.
c. Who is recruiting potential subjects?
7. a. Will email or telephone correspondence be used to screen potential subjects for eligibility
prior to the potential subject coming to the research office? Yes No
b. If yes, identify any health information and check off any of the following HIPAA
identifiers to be collected and retained by the research team during this screening process.
HEALTH INFORMATION:
_____________________________________________________________________________
HIPAA identifiers:
Names
All geographic subdivisions smaller than a State, including: street address, city, county, precinct, zip codes and their
equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly-available data from
the Bureau of the Census: (1) the geographic unit formed by combining all zip codes with the same three initial digits
contains more than 20,000 people, and (2) the initial three digits of a zip code for all such geographic units containing
20,000 or fewer people is changed to 000.
Telephone numbers
Fax numbers
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E-mail addresses
Social Security numbers
Medical record numbers
Health plan beneficiary numbers
Account numbers
All elements of dates (except year) for dates related to an individual, including: birth date, admission date, discharge
date, date of death, all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages
and elements may be aggregated into a single category of age 90 or older
Certificate/license numbers
Vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
Any other unique identifying numbers, characteristics, or codes
8. Assessment of Current Health Provider Relationship for HIPAA Consideration:
Does the Investigator or any member of the research team have a direct existing clinical
relationship with any potential subject?
Yes, all subjects
Yes, some of the subjects
No
If yes, describe the nature of this relationship.
9. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA
Authorization for either the entire study, or for recruitment purposes only. Note: if you are collecting
PHI as part of a phone or email screen, you must request a HIPAA waiver for recruitment purposes.)
Choose one: For entire study: ______ For recruitment purposes only: ______
i. Describe why it would be impracticable to obtain the subject’s authorization for
use/disclosure of this data;
ii. If requesting a waiver of signed authorization, describe why it would be
impracticable to obtain the subject’s signed authorization for use/disclosure of this
data;
By signing this protocol application, the investigator assures that the protected
health information for which a Waiver of Authorization has been requested will not
be reused or disclosed to any person or entity other than those listed in this
application, except as required by law, for authorized oversight of this research
study, or as specifically approved for use in another study by an IRB.
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject
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name, purpose, date, recipients, and a description of information provided. Logs are to be
forwarded to the Deputy HIPAA Privacy Officer.
SECTION VIII: CONSENT/ ASSENT PROCEDURES
1. Consent Personnel: List the names of all members of the research team who will be obtaining
consent/assent.
2. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will
be obtained, including parental permission or surrogate permission and the steps taken to ensure
subjects’ independent decision-making.
3. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to the
research being proposed.
4. Documentation of Consent/Assent: Specify the documents that will be used during the
consent/assent process. Copies of all documents should be appended to the protocol, in the same
format that they will be given to subjects.
5. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for
research involving non-English speaking subjects. Translated copies of all consent materials must
be submitted for approval prior to use.
6. Waiver of Consent: Will you request either a waiver of consent, or a waiver of signed consent, for
this study? If so, please address the following:
This section is not applicable to this research project
Waiver of consent: (No consent form from subjects will be obtained.)
a. Does the research pose greater than minimal risk to subjects? Yes No
b. Will the waiver adversely affect subjects’ rights and welfare? Yes No
c. Why would the research be impracticable to conduct without the waiver?
d. Where appropriate, how will pertinent information be returned to, or shared with subjects
at a later date?
Waiver of signed consent: (Verbal consent from subjects will be obtained.)
This section is not applicable to this research project
a. Would the signed consent form be the only record linking the subject and the research?
Yes No
b. Does a breach of confidentiality constitute the principal risk to subjects? Yes No
OR
c. Does the research pose greater than minimal risk? Yes No AND
d. Does the research include any activities that would require signed consent in a non-
research context? Yes No
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7. Required HIPAA Authorization: If the research involves the creation, use or disclosure of
protected health information (PHI), separate subject authorization is required under the HIPAA
Privacy Rule. Indicate which of the following forms are being provided:
Compound Consent and Authorization form
HIPAA Research Authorization Form
SECTION IX: PROTECTION OF RESEARCH SUBJECTS
1. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, discomforts,
or inconveniences associated with subjects participating in the research.
2. Minimizing Risks: Describe the manner in which the above-mentioned risks will be minimized.
3. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan
(DSMP) based on the investigator’s risk assessment stated below. (Note: the HIC will make the
final determination of the risk to subjects.) For more information, see the Instructions, page 24.
a. What is the investigator’s assessment of the overall risk level for subjects
participating in this study?
b. If children are involved, what is the investigator’s assessment of the overall risk
level for the children participating in this study?
c. Copy, paste, and then tailor an appropriate Data and Safety Monitoring Plan
from http://www.yale.edu/hrpp/forms-templates/biomedical.html for
i. Minimal risk
ii. Greater than minimal/moderate risk
iii. High risk
d. For multi-site studies for which the Yale PI serves as the lead investigator:
i. How will adverse events and unanticipated problems involving risks to subjects or
others be reported, reviewed and managed?
ii. What provisions are in place for management of interim results?
iii. What will the multi-site process be for protocol modifications?
4. Confidentiality & Security of Data:
a. What protected health information (medical information along with the HIPAA identifiers)
about subjects will be collected and used for the research?
b. How will the research data be collected, recorded and stored?
c. How will the digital data be stored? CD DVD Flash Drive Portable Hard
Drive Secured Server Laptop Computer Desktop Computer Other
d. What methods and procedures will be used to safeguard the confidentiality and security of
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the identifiable study data and the storage media indicated above during and after the
subject’s participation in the study?
Do all portable devices contain encryption software? Yes No
If no, see http://hipaa.yale.edu/guidance/policy.html
e. What will be done with the data when the research is completed? Are there plans to destroy
the identifiable data? If yes, describe how, by whom and when identifiers will be destroyed.
If no, describe how the data and/or identifiers will be secured.
f. Who will have access to the protected health information (such as the research sponsor, the
investigator, the research staff, all research monitors, FDA, QUACS, SSC, etc.)? (please
distinguish between PHI and de-identified data)
g. If appropriate, has a Certificate of Confidentiality been obtained?
h. Are any of the study procedures likely to yield information subject to mandatory reporting
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -
incidents of child abuse, elderly abuse, etc.). Please verify to whom such instances will need to
be reported.
5. Potential Benefits: Identify any benefits that may be reasonably expected to result from the
research, either to the subject(s) or to society at large. (Payment of subjects is not considered a
benefit in this context of the risk benefit assessment.)
SECTION X: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS
1. Alternatives: What other alternatives are available to the study subjects outside of the research?
2. Payments for Participation (Economic Considerations): Describe any payments that will be
made to subjects, the amount and schedule of payments, and the conditions for receiving this
compensation.
3. Costs for Participation (Economic Considerations): Clearly describe the subject’s costs
associated with participation in the research, and the interventions or procedures of the study that
will be provided at no cost to subjects.
4. In Case of Injury: This section is required for any research involving more than minimal risk.
a. Will medical treatment be available if research-related injury occurs?
b. Where and from whom may treatment be obtained?
c. Are there any limits to the treatment being provided?
d. Who will pay for this treatment?
e. How will the medical treatment be accessed by subjects?
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